BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION ROD, CONICAL T2 TIBIA Ø8 MM

    MDR report key: 3852597 · Received June 6, 2014

    Report

    Report Number
    0009610622-2014-00263
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE EXTRACTION ROD HAD BEEN IN USE FOR MORE THAN 12 YEARS, WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED WITHOUT ANY PROBLEMS REPORTED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE EXTRACTION ROD RETURNED IS DAMAGED AT THE SHAFT. SIGNIFICANT DEEP IMPRINTS, MOST LIKELY CAUSED BY ANOTHER INSTRUMENT (E.G. A FORCEPS), ARE VISIBLE ON THE SHAFT. FURTHERMORE MATERIAL ABRASION IS VISIBLE. THE IFU CONTAINS THAT THE INSTRUMENTS SHALL BE HANDLED CAREFULLY TO AVOID SUPERFICIAL DAMAGE OR ALTERATIONS TO THE GEOMETRY. IN CASE OF INTENDED USE SUCH DAMAGE WOULD NOT HAVE OCCURRED. ALTHOUGH SLIGHTLY DAMAGED THE ITEM IS STILL FULLY FUNCTIONAL, WHICH WAS VERIFIED BY THE FUNCTIONAL TEST PERFORMED. BASED ON THE ABOVE FACTS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER LINKED TO ROUGH HANDLING BY THE USER. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING A INSPECTION, IT WAS FOUND THAT THE SHAFT OF THE ROD WAS DAMAGED. ACCORDING TO THE SR, THE ROD WAS NOT USED IN THE MOST RECENT SURGERY.

    Description of Event or Problem · 1

    DURING A INSPECTION, IT WAS FOUND THAT THE SHAFT OF THE ROD WAS DAMAGED. ACCORDING TO THE SR, THE ROD WAS NOT USED IN THE MOST RECENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332554 EXTRACTION ROD, CONICAL T2 TIBIA Ø8 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K896174

    Patients

    Seq Age Sex Outcome Treatment
    1 Other